CompletedPhase 3

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

United States1,083 participantsStarted 2023-11-22

Plain-language summary

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. At least 18 years of age at the time of signing the informed consent form (ICF)
✓. At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
✓. Taking between 2 and 5 AHT medications,
✓. History of hypertension lasting at least 6 months prior to Screening
✓. Body mass index (BMI) of ≥18 kg/m2 at Screening

Exclusion criteria

✕. Women who are pregnant, plan to become pregnant, or are breastfeeding
✕. Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit
✕. eGFR \<45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
✕. Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
✕. Serum sodium \<135 mmol/L (corrected for hyperglycemia) at Screening.
✕. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.

What they're measuring

Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

Timeframe: Week 6

Trial details

NCT IDNCT06153693

SponsorMineralys Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-10

View on ClinicalTrials.gov More Hypertension trials